FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3152762
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05691
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 1, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT: ADDR01, IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED: (B)(6) 2007; 5076, IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) IMPLANTABLE PACING LEAD EXHIBITED HIGH IMPEDANCE AND HIGH THRESHOLDS. A LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255572 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR | Hospitalization| R |